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cowboyd

01/12/04 5:14 PM

#11253 RE: mikenickels #11250

Mike

There is really no need to alter the drug. Many of the rejections at this late stage are based on the percentage of people who will experience the negative side affects and the severity of them.

One of the most interesting aspects of this type of testing is that it would allow countless number of highly beneficial drugs which have either been rejected or pulled after all the intense dollars have been spent to reach this stage of development. One logical scenario would be for the FDA to approve the use of these drugs on the contingency that all users first are tested to insure they will not be subject to the negative side affects. The FDA must first recognize the validity of such a test but I suspect the costs associated with this process would be minuscule in comparison to the monies already thrown out the window by the drugs rejection. IMHO win win for everyone.

The only aspect of this type of testing scenario is that I think it would be highly unlikely that other Pharms would want a competing drug company involved. I for one would rather see the company as part of the FDA standard for testing and profiting from a steady stream of verifications than waiting for its own home run in a drug development scenario.

cowboyd